This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for RP5063 in Subjects With Schizophrenia or Schizoaffective Disorder (NCT01490086), a randomized phase 2 study. The primary outcome is Measurement of Schizophrenia Symptoms: Positive and Negative Syndrome Scale (PANSS) Total Score.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01490086 |
| Phase | Phase 2 |
| Condition | Acute Schizophrenia, Schizoaffective Disorder |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 234 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Reviva Pharmaceuticals |
| Results posted | Yes |
2. Clinical Question
Population
People with an acute exacerbation of schizophrenia or schizoaffective disorder. The registry record defines the ITT population as participants who received at least one dose, had a baseline PANSS and CGI-S assessment, and had at least one assessment of those measures without major deviations at baseline.
Intervention
RP5063 once daily in three dose groups: 15 mg, 30 mg, and 50 mg.
Comparator
Placebo once daily. The trial also included an aripiprazole 15 mg daily arm.
Primary question
How did PANSS total scores change from baseline to Day 28 across the study arms, as a measure of schizophrenia symptoms?
3. Trial Design
REFRESH is a randomized, parallel-group Phase 2 trial of RP5063 in participants with schizophrenia or schizoaffective disorder during an acute exacerbation. The registry record lists an enrollment of 234 and describes five arms: RP5063 15 mg daily, RP5063 30 mg daily, RP5063 50 mg daily, placebo once daily, and aripiprazole 15 mg daily. The study objective is to evaluate RP5063 relative to placebo for efficacy and safety.
The registry classifies the study as triple-masked. Its official title describes it as double-blind. Both descriptions are recorded, but the registry record does not explain the difference or specify which roles were masked. The study is identified as multicenter in its official title. Allocation is listed as randomized, and the model is parallel, meaning the arms are separate groups rather than treatment periods assigned sequentially to the same participants.
The record gives a start date of 2011-12, a primary completion date of 2013-03, and a status of completed. These dates describe the trial record; they do not supply the timing or conduct of individual assessments beyond the primary endpoint timeframe of baseline to Day 28.
The primary outcome is change in PANSS total score. Secondary outcomes listed in the record concern CGI-S and the PANSS positive, negative, and general psychopathology subscales. The registry record does not report a statistical analysis plan or explain how the RP5063 dose groups and aripiprazole arm were intended to be compared in a formal testing sequence.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: Subjects were screened over a period of 7 days in the site's in-patient facility. 270 subjects were recruited. Of these, 36 subjects did not meet the study eligibility criteria. Therefore, a total of 234 subjects were enrolled into the study.
Overall Study
| Stage | RP5063 15 mg | RP5063 30 mg | RP5063 50 mg | Aripiprazole 15 mg | Placebo |
|---|---|---|---|---|---|
| STARTED | 58 | 59 | 58 | 20 | 39 |
| COMPLETED | 50 | 44 | 51 | 13 | 28 |
| NOT COMPLETED | 8 | 15 | 7 | 7 | 11 |
Reasons for not completing this period:
| Reason | RP5063 15 mg | RP5063 30 mg | RP5063 50 mg | Aripiprazole 15 mg | Placebo |
|---|---|---|---|---|---|
| Consent withdrawn | 4 | 4 | 3 | 0 | 1 |
| Non-compliance | 0 | 1 | 0 | 0 | 0 |
| Abnormal laboratory findings | 1 | 0 | 0 | 0 | 0 |
| Lost to Follow-up | 0 | 0 | 0 | 0 | 1 |
| Physician Decision | 3 | 4 | 2 | 3 | 1 |
| Adverse Event | 0 | 0 | 1 | 2 | 0 |
| Lack of Efficacy | 0 | 3 | 1 | 0 | 8 |
| Worsening of symptoms | 0 | 1 | 0 | 1 | 0 |
| Subject uncontrollable and abusive | 0 | 1 | 0 | 0 | 0 |
| Subject left hospital | 0 | 1 | 0 | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: The ITT population is comprised of participants who had received at least one dose of treatment, have baseline and at least one assessment of PANSS and CGI-S without major deviations at baseline.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: The Baseline Analysis Population is the Safety Population (Total 233), which comprises all enrolled subjects (Total 234) who received at least one dose of study treatment. One Placebo subject was enrolled in the study but did not receive any study treatment.
| Characteristic | Unit | RP5063 15 mg | RP5063 30 mg | RP5063 50 mg | Aripiprazole 15 mg | Placebo | Total |
|---|---|---|---|---|---|---|---|
| Participants analysed | 58 | 59 | 58 | 20 | 38 | 233 | |
| Age, Continuous | years | 36 (SD 10) | 37 (SD 12) | 35 (SD 9) | 35 (SD 10) | 36 (SD 12) | 36 (SD 11) |
| Sex: Female, Male: Female | Participants | 17 | 9 | 16 | 2 | 11 | 55 |
| Sex: Female, Male: Male | Participants | 41 | 50 | 42 | 18 | 27 | 178 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 | 0 | 1 | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 58 | 59 | 58 | 20 | 37 | 232 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 51 | 53 | 52 | 18 | 34 | 208 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 | 1 | 1 |
| Race (NIH/OMB): Black or African American | Participants | 3 | 3 | 3 | 1 | 1 | 11 |
| Race (NIH/OMB): White | Participants | 3 | 3 | 3 | 1 | 2 | 12 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 | 0 | 0 | 0 | 0 | 1 |
| Region of Enrollment: United States | participants | 3 | 3 | 3 | 1 | 2 | 12 |
| Region of Enrollment: Philippines | participants | 15 | 15 | 15 | 5 | 9 | 59 |
| Region of Enrollment: Malaysia | participants | 10 | 11 | 10 | 3 | 8 | 42 |
| Region of Enrollment: Moldova, Republic of | participants | 3 | 3 | 3 | 1 | 2 | 12 |
| Region of Enrollment: India | participants | 27 | 27 | 27 | 10 | 17 | 108 |
6. Primary Endpoint
The registry lists the primary outcome as Measurement of Schizophrenia Symptoms: Positive and Negative Syndrome Scale (PANSS) Total Score, measured over Baseline to Day 28.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | scores on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change in the Positive and Negative Syndrome Scale (PANSS) total score from baseline to Day 28. PANSS combines ratings from positive symptoms, negative symptoms, and general psychopathology. The total score is obtained by adding ratings across the items in those scales. The total-score range is 30-210, and a higher score reflects a worse outcome; a larger reduction from baseline reflects a better outcome on this measure.
PANSS is used to quantify symptom severity in the clinical domains captured by its component scales. Repeated assessment allows researchers to describe whether scores changed over the specified period. For a randomized trial, comparing changes between groups can help distinguish the pattern observed in one assigned arm from the pattern observed in another, although interpretation depends on the analysis and the uncertainty around estimates.
The registry record also lists change from baseline in CGI-S and in the PANSS positive, negative, and general psychopathology subscales as secondary outcomes. The primary endpoint is described as a mean with standard deviation. Arm-level means, standard deviations, and changes in PANSS total score are not reported in the registry record, so the direction and precision of any between-group difference cannot be assessed from the recorded information.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record establishes the trial’s question and endpoint, but it does not report the numerical PANSS results needed to answer that question. Arm-level baseline and Day 28 scores, changes from baseline, between-group estimates, confidence intervals, and p-values are not reported in the registry record. The primary outcome is flagged as having several categories or time points and is not reduced to one comparison. Consequently, no single numerical treatment contrast can be described from the available record.
This absence is not evidence that groups had the same outcomes, nor does it show that a difference was present. A conclusion in either direction would require results that are not reported in the registry record. The trial status is completed, but completion status alone does not establish the direction, size, or statistical precision of the primary endpoint findings.
The study included three RP5063 dose groups, a placebo group, and an aripiprazole group. Those arms create several possible comparisons, but the registry record does not report which comparisons were used for the primary analysis, whether the dose groups were tested separately against placebo, or how the aripiprazole arm figured in the analysis. It would therefore be inappropriate to select one contrast or treat the arms as if their results were interchangeable.
The endpoint’s interpretation also depends on how the reported change is defined and analyzed. A reduction in PANSS total score corresponds to improvement on the scale’s scoring direction, but an observed within-group reduction by itself would not establish a comparative treatment effect. The relevant evidence for a randomized comparison would include the difference between groups and its uncertainty, alongside a clear account of the population and analysis used. Those results and details are not reported in the registry record.
Safety information is available as counts of participants affected by serious and other adverse events, but it is not accompanied by comparative uncertainty estimates or a complete narrative of adverse events. The counts can describe what was recorded in each group, but they do not by themselves establish whether differences between groups are reliable or attributable to treatment.
The registry record reports a planning illustration based on an observed effect, with assumptions including a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. Any sample-size figures associated with that illustration are planning quantities rather than evidence of achieved statistical power. They do not substitute for the missing outcome estimates, and they do not reveal the trial’s original design justification, which is not reported in the registry record.
9. Statistical Methods Explained
What does a mean and standard deviation describe?
The primary outcome is continuous: each participant has a PANSS total score, and the registry specifies that the parameter is a mean with standard deviation. In general, a mean describes the center of a set of scores. A standard deviation describes how dispersed individual scores are around that mean. The mean can give a compact summary of a group, while the standard deviation indicates whether scores are relatively clustered or spread out.
These summaries do not fully describe the distribution of scores, and they do not show how much the groups overlap. They also do not, by themselves, give the uncertainty in a comparison between groups. To interpret a treatment contrast, readers need an estimate of the difference and a measure of its precision, such as a confidence interval. A confidence interval is a range of values compatible with the data and the statistical method under its assumptions; a narrower interval generally indicates greater precision. No such interval for PANSS total score is reported in the registry record.
Why distinguish change from baseline from a group comparison?
Change from baseline summarizes how scores differ between a participant’s starting assessment and a later assessment. Because higher PANSS scores reflect worse outcomes, a larger reduction represents a more favorable change on the scale. But a group’s average change is not the same as the difference in change between two groups. In a randomized trial, the comparative question concerns how the groups’ outcomes differ, not simply whether one group’s score moved over time.
In general, a comparison can be expressed as a difference in mean change or through another prespecified model. The registry record does not report the analysis method, the numerical group changes, or a between-group estimate. It is therefore not possible to determine from the record how the primary comparison was calculated or how precisely it was estimated.
What is known about the analysis population?
The record defines the ITT population as participants who received at least one dose of treatment, had baseline PANSS and CGI-S assessments, and had at least one assessment of PANSS and CGI-S without major deviations at baseline. This definition identifies eligibility for the stated population; it does not report how many participants met it or how many contributed to the primary endpoint analysis.
The term ITT is often used for analyses that preserve randomized assignment, but the specific definition recorded includes treatment receipt and assessment requirements. The registry record does not explain how these criteria were handled in practice, whether participants were analyzed according to assigned treatment, or whether other analysis populations were used. The statistical analysis population actually used for the primary result is not reported in the registry record.
How should the planning illustration be understood?
The record describes a planning illustration computed from an observed effect. Its stated assumptions include a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is specified as a fraction of the observed effect. This is a hypothetical planning exercise. It is not a record of the trial’s original sample-size justification, and sample-size planning values must not be interpreted as observed power.
In general, a sample-size calculation asks how much information a proposed study would need to have a chosen chance of detecting an effect under specified assumptions. The answer depends on the effect size used, outcome variability, allocation, and testing approach. If the effect used for planning comes from observed results, it can be uncertain and may not represent the effect a future study would encounter. The registry record does not report the original sample-size justification or its assumptions.
Power is a property of a design and assumed effect under a statistical model, not a retrospective measure that proves whether a particular trial result is reliable. Once a study is complete, readers should focus on the estimated effects and their uncertainty rather than interpreting a post hoc power calculation as evidence for or against an effect. No primary outcome estimates are reported in the registry record for that interpretation.
Why can multiple outcomes and arms complicate interpretation?
The record lists the primary PANSS total score and secondary outcomes involving CGI-S and three PANSS subscales. It also records multiple treatment arms. In general, making many statistical comparisons can increase the chance that at least one result appears notable by chance. Multiplicity procedures can address this issue by defining which comparisons matter and how evidence is evaluated across them. The registry record does not report whether such procedures were planned or used.
The record lists zero analyses. This does not establish that no statistical work was conducted; it means analysis details are not present in the registry entry. Methods for handling missing outcome data, baseline adjustment, multiplicity, and model assumptions are not reported in the registry record. Without those details and without the primary numerical results, the effect and its uncertainty cannot be independently interpreted from the entry.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists one primary outcome, change in PANSS total score from baseline to Day 28, and secondary outcomes for CGI-S and the PANSS positive, negative, and general psychopathology subscales. It records five outcome measures and zero analyses. The entry does not specify a multiplicity strategy, such as whether secondary outcomes were exploratory or whether statistical testing across outcomes or dose groups was adjusted. The intended order and role of comparisons among the three RP5063 doses, placebo, and aripiprazole are not reported in the registry record.
Missing-data handling is also not reported in the registry record. There is no description of how unavailable Day 28 assessments, withdrawals, or other incomplete outcome records were treated. The record does not specify whether imputation, a likelihood-based approach, or another method was used, so none should be assumed.
The stated ITT population requires at least one treatment dose, baseline PANSS and CGI-S assessments, and at least one assessment of those measures without major deviations at baseline. The number of participants meeting this definition, the number analyzed for the primary outcome, and the handling of participants outside that definition are not reported in the registry record. The entry also does not describe a per-protocol or safety analysis population.
These omissions matter because the analysis population, missing-data approach, and multiplicity plan affect how estimates and uncertainty should be interpreted. Without those details and the numerical outcome results, the registry record does not permit a complete assessment of the primary analysis.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| RP5063 15 mg | 1 | 58 | 1.7% |
| RP5063 30 mg | 1 | 59 | 1.7% |
| RP5063 50 mg | 1 | 58 | 1.7% |
| Aripiprazole 15 mg | 2 | 20 | 10.0% |
| Placebo | 0 | 38 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 2% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| RP5063 15 mg | 29 of 58 |
| RP5063 30 mg | 30 of 59 |
| RP5063 50 mg | 37 of 58 |
| Aripiprazole 15 mg | 10 of 20 |
| Placebo | 23 of 38 |
Most frequent serious adverse event terms
| Event term | Organ system | RP5063 15 mg | RP5063 30 mg | RP5063 50 mg | Aripiprazole 15 mg | Placebo |
|---|---|---|---|---|---|---|
| Elevated liver enzyme levels | Investigations | 1 of 58 | 1 of 59 | 1 of 58 | 1 of 20 | 0 of 38 |
| Sedation excessive | Nervous system disorders | 0 of 58 | 0 of 59 | 0 of 58 | 1 of 20 | 0 of 38 |
Most frequent non-serious adverse event terms
| Event term | Organ system | RP5063 15 mg | RP5063 30 mg | RP5063 50 mg | Aripiprazole 15 mg | Placebo |
|---|---|---|---|---|---|---|
| Insomnia | Psychiatric disorders | 16 of 58 | 15 of 59 | 10 of 58 | 4 of 20 | 8 of 38 |
| Agitation | Psychiatric disorders | 6 of 58 | 6 of 59 | 4 of 58 | 4 of 20 | 6 of 38 |
| Extrapyramidal disorder | Nervous system disorders | 2 of 58 | 3 of 59 | 5 of 58 | 1 of 20 | 0 of 38 |
| Akathisia | Nervous system disorders | 1 of 58 | 3 of 59 | 6 of 58 | 0 of 20 | 0 of 38 |
| Restlessness | Psychiatric disorders | 1 of 58 | 3 of 59 | 2 of 58 | 1 of 20 | 3 of 38 |
| Headache | Nervous system disorders | 3 of 58 | 1 of 59 | 2 of 58 | 1 of 20 | 1 of 38 |
| Pyrexia | General disorders | 1 of 58 | 0 of 59 | 3 of 58 | 1 of 20 | 2 of 38 |
| Tremor | Nervous system disorders | 1 of 58 | 3 of 59 | 2 of 58 | 0 of 20 | 1 of 38 |
| Nausea | Gastrointestinal disorders | 1 of 58 | 1 of 59 | 2 of 58 | 0 of 20 | 1 of 38 |
| Hepatic enzyme increased | Investigations | 2 of 58 | 1 of 59 | 1 of 58 | 1 of 20 | 0 of 38 |
Serious events with the highest arm-level rate: elevated liver enzyme levels (5.0%), sedation excessive (5.0%).
The safety record gives group-specific counts of participants at risk and participants affected by serious adverse events. For RP5063 15 mg, 1 of 58 participants was affected; for RP5063 30 mg, 1 of 59; for RP5063 50 mg, 1 of 58; for aripiprazole 15 mg, 2 of 20; and for placebo, 0 of 38. These are descriptive counts in the registry record, not estimates of comparative risk with uncertainty.
The record also lists other adverse events affecting 29 participants in the RP5063 15 mg group, 30 in the RP5063 30 mg group, 37 in the RP5063 50 mg group, 10 in the aripiprazole 15 mg group, and 23 in the placebo group. The registry record lists elevated liver enzyme levels and excessive sedation among the top serious adverse event terms, each at 5.0%. It does not provide further context for those percentages in the information recorded.
Deaths are not reported in the registry record. Counts alone do not describe event timing, duration, severity beyond the serious classification, or the statistical uncertainty around differences between groups. They should be read as recorded safety summaries, not as proof of a treatment-related cause or a comparative conclusion.
12. What the Result Does, and Does Not, Mean
The registry record describes a randomized Phase 2 study designed to evaluate RP5063 relative to placebo in people with schizophrenia or schizoaffective disorder during an acute exacerbation. It identifies PANSS total score change from baseline to Day 28 as the primary endpoint, and lists several secondary symptom measures. It also documents the dose groups and the presence of placebo and aripiprazole arms.
Those design details establish what the trial set out to study, but the primary numerical results are not reported in the registry record. Without group outcome summaries and a comparative estimate with its precision, the record does not show the size or direction of a PANSS difference between arms. It therefore cannot support a conclusion that RP5063 improved symptoms, had no effect, or differed from a comparator. Lack of a reported result is not evidence of no difference.
The safety counts provide descriptive information about participants affected by serious and other adverse events. They do not establish whether observed differences between groups are statistically precise, nor do the counts alone establish that an event was caused by a treatment. Deaths are not reported in the registry record.
In general, a clinical trial result is interpreted by considering the estimated effect, its uncertainty, the analysis population, missing-data handling, and the planned comparisons. Those elements are especially important when a study includes multiple doses, several outcomes, and an additional active arm. The registry record does not report the analysis details needed to assess those aspects fully.
The planning illustration described in the record is not a substitute for trial results. Planning estimates address hypothetical study requirements under stated assumptions; they are not observed power and do not determine what the trial found. The appropriate conclusion from the available registry information is limited to the design, endpoints, and recorded safety counts, with efficacy results and several statistical methods not reported in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically notable for its multiple-arm structure: it includes three RP5063 dose groups, placebo, and aripiprazole. That design can address more than one dose and more than one comparator question, but it also makes clarity about the primary contrast and the analysis plan important. The registry record does not report a testing sequence or multiplicity procedure, so readers cannot determine how the several possible comparisons were handled.
The chosen primary endpoint is a continuous symptom score measured over baseline to Day 28. A mean and standard deviation can summarize the scores, while a comparative estimate and confidence interval would be needed to understand the magnitude and precision of differences between arms. Those numerical results are not reported in the registry record. As a result, the design is visible, but the evidence needed to quantify the primary treatment contrast is not.
The study also illustrates why enrollment and completion status are not substitutes for analysis information. The record lists an enrollment of 234 and a completed status, but does not give the primary analysis sample size, the missing-data approach, or the outcome estimates. Those features determine how much information is available for interpretation and which population the result represents.
Finally, the recorded ITT definition is specific: it includes treatment receipt and assessment requirements. Reporting the number of participants who met that definition and explaining how they were analyzed would help readers connect the registered population to the final estimates. In the absence of those details, conclusions should remain limited to the registered design and the outcomes and safety counts recorded.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The central limitation of the registry record for interpreting efficacy is that it does not report the numerical primary outcome results. PANSS total score changes, group means and standard deviations, comparative estimates, confidence intervals, and p-values are not reported in the registry record. The primary outcome is flagged as having several categories or time points and is not reduced to one comparison, so a single result cannot be summarized.
The record does not specify the primary statistical model, the planned contrasts among the RP5063 dose groups and comparators, baseline adjustment, or a multiplicity strategy. It lists secondary outcomes but does not say how their results were intended to relate to the primary question. Missing-data procedures and the number of participants included in each outcome analysis are also not reported in the registry record.
Although the entry defines an ITT population, it does not state how many participants met that definition or describe how the definition was applied in analysis. The record also does not report the original sample-size justification. Its planning illustration is based on an observed effect and stated assumptions; it should not be treated as the trial’s original design rationale or as observed power.
For safety, the registry gives counts but not uncertainty estimates, event timing, or a detailed account of the listed terms. Deaths are not reported in the registry record. These limits mean that the recorded counts can be described, but their comparative precision and context cannot be established from the registry entry alone.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: RP5063 in Subjects With Schizophrenia or Schizoaffective Disorder — NCT01490086.
- Registry record last updated 2025-08-08; status last verified 2025-07.
- Results first posted 2015-01-26.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT01490086 is the completed Phase 2 REFRESH randomized, parallel-group trial of RP5063 in participants with schizophrenia or schizoaffective disorder during an acute exacerbation. The record lists enrollment of 234, a start date of 2011-12, and primary completion in 2013-03. It includes RP5063 15 mg, 30 mg, and 50 mg daily arms, placebo, and aripiprazole 15 mg daily. The registry design fields specify triple masking; the official title describes the study as double-blind.
The primary endpoint is PANSS total score change from baseline to Day 28. Secondary outcomes concern CGI-S and PANSS subscales. Numerical primary efficacy results and key analysis details are not reported in the registry record. Serious and other adverse event counts are recorded by group, while deaths are not reported.